SYLLABUS
EMA 6580, Section 5031
BIOMATERIALS
FALL 2001
Instructor: Dr. C. Batich
3 Credits
Office: 317 MAE
M: Tuesday (2nd & 3rd), Thursday (3rd)
Tel: 392-6630
Room: NEB 0101 (T), LARSEN 239 (TH)
E-mail: cbati@mse.ufl.edu
Office Hours: By appointment
Dept. Chair: Dr. R. Abbaschian (phone 846-3301,100B Rhines Hall, Box 116400)
Grading: (approximate)
Three Tests
Student Presentations (including audience participation)
Student Paper/Proposal (due last day of class, December 4th)
Device Sheet (due September 11th)
50%
10%
30%
10%
OUTLINE OF CONTENT
Part I
Part II
Part III
Topic
First Class/Introduction
Scope
Natural Biomaterials
Metals and Ceramics
Polymers
Degradation Problems
Biocompatibility - Toxicology
Tissue Response/Histology
Protein Adsorption, Thrombogenicity, Complement / Quiz #1
Reactive Implants, Bioglass
Soft Tissue Implants (Inert)
Degradable Implants/Skin
Joints
Tendons, Ligaments
Dental Materials
Quiz #2
Ophthalmological Materials
Catheters
Sensors
Devices
Hybrid Devices
Controlled Drug Delivery
Syllabus
EMA 6580 - Biomaterials
Part IV
Page 2
Topic
Sterilizations and Infections
Regulations/Quiz #3
Student Presentations
Guest Speakers
Papers Due
(Last Day of Class)
Topics listed will vary somewhat from listings depending on the amount of detail and interest for
each one. Make suggestions if you would like to see certain areas covered.
BIOMATERIALS - FALL 2001
Report:
One page, single-spaced, see attached example.
Current Materials and Problems: (emphasis on current clinical use)
1. Hydrocephalic shunts (drains)
2. Intra-ocular lens
3. Contact lens
4. Adjuvants for immunization
5. Finger joints
6. Fillings (dental restorations)
7. Caps (dental restorations)
8. Hip implant - bone attachment
9. Hip implant - low friction surface (sliding part)
10. Cardiac catheter (balloon angioplasty)
11. Pacemaker electrodes
12. Transdermal drug delivery patches
13. Heart valves (treated, natural)
14. Heart valves (totally synthetic)
15. Dialysis tubing
16. Extra corporeal membrane oxygenator (ECMO) - membranes
17. Ligaments
18. X-ray contrast media: liquids (usually for angiography)
19. Skull plate/reconstruction
20. Tympanic membrane (ear)
21. Ear drainage tubes (myringotomy tubes)
22. Blood bags
23. Artificial blood
24. Foley catheters (urinary)
25. Implantable defibrillator electrodes
26. Guided tissue regeneration scaffolds
27. Ureteral stents
EXAMPLE
EMA 6580 - BIOMATERIALS
August 22, 2001
Summary of a Medical Device
Chris Batich
Vascular Grafts (Arterial)
A Common Use: Replacement of aneurysm of abdominal aorta (common ballooning was visible and
eventually fatal) about 300,000/year in USA.
History: Pre-1960: Piano wire, epoxy resin or treated cellulose sheets. 1952: (Voorhees and
Blakemore), replacement of 17 aneurysms with synthetic tube (Vinyon-N) used in parachute cloth: a
copolymer of vinylchloride and acrylonitrile.
Materials Used (current underlined): Autologous, Vinyon-N, nylon, Dacron (PET), expanded PTFE
Classification (FDA.gov): (optional)
< 6mm: Class III (pre-market approval)
Current Problems: Poor endothelial growth, poor performance in slow flow or narrow (< 6mm)
areas, infections, kinkability, occlusion, fatigue failure (dilation, rupture and at anastamosis),
increased problems distal to graft.
Speculation on Future Use: Combined structure: "rip-stop" Dacron seeded with endothelium matrix
and cells, better match of modulus (i.e., composite Dacron + elastomer).
Experimental Studies (Currently):
Endothelial seeding before implantation
Glutaraldehyde stabilized human umbilical cord
Polyurethane or silicone replamine (sea urchin spine)
Acellular vascular matrix
Surface modified synthetics
Collagen impregnation
Reference:
1.
2.
3.
Clinical Experience with a Collagen Impregnated Woven Dacron Graft, Tolan M., Wells F.,
Kendall S., Large S., Wallwork J., J Cardiovasc Surg Torino, 36(4): 323-7 (1995).
Seeding with Omental Cells Prevents Late Neointimal Hyperplasia in Small-Diameter Dacron
Grafts, Pasic M., Muller-Glauser W., Odermatt B., Lachat M., Seifert B., Turina M.,
Circulation, 92(9): 2605-16 (1995).
Follow-up Results of Synthetic Vascular Grafts in Children Undergoing Hemodialysis, Nayir
A., Sonmez Y., Sirin A., Emre S., Aydogan U., Turk J Pediatr., 37(3): 223-8 (1995).
FALL 2001 COURSE OFFERING - UNIVERSITY OF FLORIDA
EMA 6580 - BIOMATERIALS
Graduate Catalog Description:
Undergraduate chemistry essential. Introduction to variables that control compatibility and
performance of biomaterials, including physical and chemical properties, corrosion, fatigue, and
interfacial histo-chemical changes.
Textbook(s): None.
Computer Use: needed for searching medical databases, web.
Professor: C.D. Batich, Professor of Materials Science and Engineering - (352) 392-6630.
Overview:
This course is an introduction to the field of biomaterials from a materials science point of view.
The goal is to understand materials selection, trade-offs and the limitations imposed by current
materials on device performance. Initial sections will deal with an overview of important medical
devices, their role in health care and their economic importance. A second section will describe the
basic materials currently used. Polymers, metals and ceramics will be discussed and their major
properties for medical applications examined. Properties discussed will include chemical stability
(including metallic corrosion), mechanical properties and normal impurities present (e.g., residual
monomers and antioxidants) which may influence biomedical use. Polymers will be emphasized.
A third section will examine the meaning of "biocompatibility," with reference to the range of
biological responses and environments available. Thrombogenicity, immunoresponse and various
histological responses will be covered. An introduction to tissue types and the response of such
types to implants will be presented. Finally, a number of major applications will be covered with
discussion of current materials, limitations, and possible new research directions. These will include
joints, organs (e.g., pancreas) and surgical aids such as adhesives and sutures.
A paper will be required examining one aspect of biomaterials use in detail.
The instructor will be Dr. C. Batich who conducts research on polymeric biomaterials in the
Materials Science and Engineering Department at the University of Florida in conjunction with the
College of Medicine and the College of Dentistry.
EMA 6580: Biomaterials
Final Paper: A biomaterials related research proposal in NIH format. It can be a new material, a new design,
an evaluation of treatments, etc. Remember to emphasize materials used. Ask someone to read your report
over before turning it in for obvious problems or grammar errors.
A. Content
8-12 pages in length (double-spaced, i.e., about 250 words/pg for text, number pages, include name and
date, 10 pt. type or larger).
1.
Abstract: half page maximum (not on a separate page). Mention novel aspect of approach (your
contribution).
2.
Specific Aims: a numbered list (at least 3) of specific objectives (e.g., “measure the number of
particles engulfed per macrophage averaged over at least ten cells”). Don't be general or vague
("measure biocompatibility of . . . "). Notice that the example given mentions specific materials
(calcium) and numbers.
3.
Background: include a clear statement of an existing problem or gap in knowledge to be
addressed (no more than one page).
4.
Technical Approach (methods): this is the core of the proposal. Include diagrams and planned
experiments, both fabrication and testing, with expected results (ranges) and usefulness of the
result to future use. Define abbreviations (e.g., THF is tetrahydro furan). Sketches are ok. I am
more interested in content than nice graphics.
5.
References: current and germane; please include titles of articles. If you make a general
statement ("The major cause of... is...") reference it. Also reference any figures used. Include
data in a standard format such as: author, title of article, title of journal, volume, pages, and year.
B. Grading
Primary: originality, practicality, well justified testing (technical approach).
Secondary: format, references, communication quality (syntax, typos, and grammar).
C. Use Health Center Library:
1.
Network searching: NIH.gov (PubMed).
2.
Medical Device Register (reference book, on reserve in library).
3.
NIH Guide, available on-line.
D. Use of Ideas
Include one of the following sentences (or make up your own) to add after the references.
1.
Confidential--please don't discuss this idea with anyone.
2.
OK to discuss subject, I'd like to work on it though.
3.
OK to discuss subject, please let me know if anyone works on it.
4.
Free to discuss or develop or propose.
 C. Batich, Fall 2001 File Proposal